Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (IONS-UVFP)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Unilateral Vocal Cord Paralysis

Treatments: Other: Sham of voice therapy; Procedure: Acid hyaluronic injection laryngoplasty; Behavioral: Voice therapy; Other: Sham of injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03906877

2018/03OCT/365

Details and patient eligibility

About

The aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Unilateral paralysis in abduction of the vocal cords may be included in the study.

Exclusion criteria

• Wear a pacemaker or other implanted devices (prostheses ...).
• Wear metal clips, metal in the head, or an adjustable brain drain.
• Wear non-removable dental appliances (except fillings).
• Wear cardiac valve prostheses.
• Have worked the metals.
• Have a tattoo containing metal particles.
• Have implanted jewelry (e.g., piercing).
• Being prone to epileptic seizures.
• Take medications that alter cortical excitability.
• Have had a brain surgery.
• Suffer from intracranial hypertension.
• Be pregnant or breastfeeding recently.
• Present allergies that are incompatible with the experimental protocol.
• Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 3 patient groups

Injection laryngoplasty group (IL)

Experimental group

Description:

The patients in the first group will receive an IL of hyaluronic acid in the paralyzed vocal fold within a maximum of three months after the onset of symptoms. The Ear-Noise-Throat (ENT) physician will perform the injection in office, under topical anaesthesia.

Treatment:

Procedure: Acid hyaluronic injection laryngoplasty

Other: Sham of voice therapy

Voice therapy group (VT)

Experimental group

Description:

Patients from the second group will be involved in 15 sessions of thirty minutes of voice therapy, twice a week, and will have to do home practice. Patients will have to record these training sessions. Initiation of this intervention should also take place within the first three months after the onset of symptoms. They will also receive an injection of physiological saline under the skin of the neck (sham of injection).

Treatment:

Other: Sham of injection

Behavioral: Voice therapy

Sham group

Sham Comparator group

Description:

The patients of the third group will be treated following the traditional wait-and-see policy. They will receive an injection of physiological saline under the skin of the neck and will be seen during 15 sessions of 30 minutes, twice a week. Therefore, this will be a sham procedure for both IL and VT.

Treatment:

Other: Sham of injection

Other: Sham of voice therapy